Tag Archives: World Health Organization (WHO)

United States federal and state rules and regulations during public health emergencies: navigating novel coronavirus

On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and the United States Department of Health and Human Services (HHS) named it a public health emergency (PHE). In the United States, the declaration of a PHE empowers HHS to … Continue Reading

FDLI Publishes New Guide to International Prescription Product Recalls

Recent events highlight the importance of having a plan for product recalls. The Food and Drug Law Institute's recent monograph entitled, "International Prescription Product Recalls: A Practical Guide, Volume 1, Number 4," provides comprehensive guidance and practical recommendations on dealing with recalls internationally as well as a checklist and valuable "dos and don'ts" for manufacturers facing product recalls. Written by Reed Smith partners James M. Wood and Areta L. Kupchyk, the publication is available for download by series and individual issue subscribers. For more information or to order, see www.fdli.org.… Continue Reading
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